Paliperidone Extended-Release Tablets for the Treatment of Methamphetamine Use Disorder in Chinese Patients After Acute Treatment: A Randomized, Double-Blind, Placebo-Controlled Exploratory Study.

Gang Wang,Sheng Zhang,Zaifeng Xu,Wei Hao,Yongde Yang,Xue Yang,Li Ma,Xuebing Liu

doi:10.3389/fpsyt.2019.00656

Abstract

Background: To test paliperidone extended-release (ER) for efficacy in decreasing methamphetamine (METH) use and reducing psychotic symptoms in METH-dependent patients after detoxification. Rates of adverse events with paliperidone ER versus placebo were also compared. Methods: After discharge and 7 days without medication, 80 treatment-seeking METH-dependent participants were randomly assigned to paliperidone ER (3 mg once daily; n = 40) or placebo (once daily; n = 40) for 84 days under double-blind conditions. The participants attended clinics weekly to provide urine samples that were analyzed for METH metabolites, to complete research assessments, and to receive substance use and medication counseling. Results: Fifty-six percent of follow-up visits and final visits were completed. The placebo group had a significantly lower retention [51.5 days; 95% confidence interval (CI), 41.6–61.4] than the paliperidone ER group (69.4 days,; 95% CI, 61.9–76.9; p = 0.016). Paliperidone ER was a protective factor against psychotic symptom relapse [hazard ratio (HR) = 0.15, p = 0.003]. Moreover, there were statistically significant effects of paliperidone ER on psychosis severity and METH craving, assessed by mean changes in Positive and Negative Syndrome Scale (PANSS) total scores, Clinical Global Impression—Severity (CGI-S) scores, and METH craving scores over time (p = 0.006, p = 0.002, and p = 0.03 for the medication-by-time interaction effect, respectively). There were no statistically significant differences between the two groups in METH use. There were no serious adverse events related to the study drug. Conclusion: Compared with placebo, paliperidone ER administration resulted in a better retention rate and lower psychotic symptom relapse, but we did not find significantly reduced METH use among adults after acute METH detoxification treatment.

Highlights

The use of methamphetamine (METH), an amphetaminetype stimulant (ATS), has increased to epidemic proportions worldwide, with an estimated 35 million people who used ATS drugs in 2015 [1]
One hundred and fifty-one individuals were deemed eligible, and 80 agreed to participate and were randomized in the trial. Those who were eligible but did not participate in the trial were similar in age, race/ethnicity, and METH use status to those who were randomized
Our results indicated that participants in the paliperidone ER group had a substantially lower risk of psychosis recurrence than the subjects in the placebo group (HR = 0.15, p = 0.003)

Summary

Introduction

The use of methamphetamine (METH), an amphetaminetype stimulant (ATS), has increased to epidemic proportions worldwide, with an estimated 35 million people who used ATS drugs in 2015 [1]. Over 50% of patients relapsed to METH use after treatment discharge [5, 6] due to the high potential for abuse and addiction to METH. This means that most patients had suffered the recurrence of psychosis resulting from METH relapse. To test paliperidone extended-release (ER) for efficacy in decreasing methamphetamine (METH) use and reducing psychotic symptoms in METH-dependent patients after detoxification. Rates of adverse events with paliperidone ER versus placebo were compared

Methods

Results

Conclusion